Brisdelle

"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.

Brisdelle

Antidepressants, including selective serotonin
reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal
thoughts and behavior in pediatric and young adult patients when used to treat
major depressive disorder and other psychiatric disorders. Because BRISDELLE is
an SSRI, monitor patients closely for worsening and for emergence of suicidal
thoughts and behaviors. Advise families and caregivers of the need for close
observation and communication with the prescriber [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION

BRISDELLE (paroxetine) is an orally administered
selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to
severe VMS associated with menopause. It is identified chemically as (-)-trans
-4R- (4'-fluorophenyl) - 3S - [(3', 4'-methylenedioxyphenoxy) methyl]
piperidine mesylate and has the empirical formula of C19H20FNO3•CH3SO3H.
The molecular weight is 425.5 (329.4 as free base). The structural formula is:

The mesylate salt of paroxetine is an odorless, off-white
powder, having a melting point range of 147° to 150°C and a solubility of more
than 1 g/mL in water.